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WO2014058828A2 - Procédé et dispositif de gestion de site d'intervention de gaines et de cathéters - Google Patents

Procédé et dispositif de gestion de site d'intervention de gaines et de cathéters Download PDF

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Publication number
WO2014058828A2
WO2014058828A2 PCT/US2013/063802 US2013063802W WO2014058828A2 WO 2014058828 A2 WO2014058828 A2 WO 2014058828A2 US 2013063802 W US2013063802 W US 2013063802W WO 2014058828 A2 WO2014058828 A2 WO 2014058828A2
Authority
WO
WIPO (PCT)
Prior art keywords
access
pad
access lumen
retention
managing
Prior art date
Application number
PCT/US2013/063802
Other languages
English (en)
Other versions
WO2014058828A3 (fr
Inventor
Mark E. Zyzelewski
Brian O. TIERNEY
Sean R. COLLINS
Original Assignee
Lakeshore Medical Innovations, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lakeshore Medical Innovations, Llc filed Critical Lakeshore Medical Innovations, Llc
Publication of WO2014058828A2 publication Critical patent/WO2014058828A2/fr
Priority to US14/682,347 priority Critical patent/US20150217088A1/en
Publication of WO2014058828A3 publication Critical patent/WO2014058828A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0253—Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like

Definitions

  • This invention is in the field of devices used to secure and properly retain sheaths and catheters that may be used during an interventional catheterization procedure.
  • sheaths and catheters that are used to gain access to the patient's vasculature. Once access is achieved, the sheaths and catheters are used to introduce fluids and devices directly into the patient vasculature.
  • the devices may include, but are not limited to, guide wires, catheters, angioplasty balloons, and stent delivery systems.
  • the sheaths and catheters remain in the patient' s artery throughout the entire procedure, and multiple devices can be inserted and removed during the procedure. While inserting and removing devices, it is not uncommon for the sheath to move with the movement of the device. This movement is not ideal and can cause the sheath to slide out of position. The sheath can move farther into the artery or slide out of the artery depending on the movement. Either situation can create issues which negatively affect the procedure.
  • the vessel can spasm and contract, making it difficult to insert and remove devices.
  • the spasms can also make it difficult to remove the sheath. If the sheath loses its position by moving out of the vessel, artery access can be completely lost.
  • the sheath is taped to the skin to attempt to retain its position.
  • the tape used is a polyurethane skin dressing. This process of using the dressing can be cumbersome.
  • the dressing completely covers the sheath opening and must be modified to allow access to the proximal end, or opening, of the sheath.
  • the modification of the dressing can weaken the structure of the dressing, and reduce the effectiveness during the repeated movements of devices through the sheath. Another issue is the adhesion of the dressing to the access site and sheath throughout the procedure.
  • the adhesives used on the dressings do not perform as well when exposed to fluids. The continued exposure to the fluids throughout the procedure can weaken the bond of the dressing to the sheath and the skin, and therefore lead to unwanted movement of the sheath.
  • the present invention is a securement device whose goal is to securely retain the access lumen, such as a sheath or catheter, throughout the procedure without being affected by movement of the devices through the sheath.
  • the device also has features which help maintain the adhesion of the device to the skin when fluids are seen during the procedure.
  • the device is also designed to fit with various access lumen types.
  • a method of managing an access site and site management device for an interventional cardiology access lumen having a cylindrical hub and a tubular portion extending from the cylindrical hub includes adhering an adhesive pad directly or indirectly to a patient at an intervention cardiology access site. After the adhering, an access lumen is deployed and a portion of the access lumen positioned against a retention pad that is supported by the adhesive pad.
  • the retention pad has a surface configured to the portion of the access lumen.
  • the access lumen is retained to the retention pad with a top retention strip.
  • the retention pad surface configuration may have a receiving geometry complimentary to that of the hub.
  • the retention pad surface will have a partial-circular shape configured to the size and shape of the cylindrical hub of the access lumen.
  • the retention pad surface configuration may include side ribs that are configured to the size and shape of a side port of the access lumen. The side ribs may extend laterally in opposite directions from the partial-circular shape to allow the side port of the access lumen to extend in either lateral direction.
  • Proximal access may be provided to an insertion hole in the access lumen that is positioned against the retention pad and retained by the top retention strip.
  • the top retention strip may be an adhesive strip.
  • the top retention strip may define a through- channel and the method includes passing an extension of the side port through the channel.
  • the adhesive pad may include another through-channel that aligns with the through-channel in the top retention strip and the extension of the side port may pass through both through-channels.
  • the adhesive pad may be adhered directly to the patient by wrapping the adhesive pad at least partially around the patient's extremity, such as the wrist or ankle.
  • the adhesive pad may be adhered indirectly to the patient by adhering the adhesive pad to a drape at the intervention site. Access may be provided to an insertion opening at the hub of the retained access lumen.
  • One embodiment of the invention is to make an access site management device which fits with all components from all sheath manufacturers.
  • One feature is a round hub for insertion of interventional devices.
  • the hub is cylindrical in shape with the proximal end of the hub having a hole for insertion of devices, and the distal end of the hub attaching to the tubular sheath which is inserted into the patient' s artery.
  • the other feature that is common is a side port attached to the hub of the sheath.
  • the side port is used for injection fluids into the patient.
  • the side port exits the hub normal to the axis of the sheath.
  • the securement device incorporates an overall circular cross-sectioned retention pad.
  • This circular sectioned pad allows for engagement with the cylindrical hub of the sheath.
  • Protruding normal to the axis of the circular section is a rib which engages with the side port of the sheath.
  • this rib contains a front and back side, which captures the side port, and prevents the movement of the sheath along the axis of the sheath. Therefore, as devices are moved in and out of the sheath, the sheath is held rigidly and prevents any movement.
  • the securement device incorporates a circumferential adhesive strip which adheres to the skin at the access site and circumferentially to both sides of the device. This circumferential adhesion ensures strong adhesive bonds to the skin even if the access site and sheath encounter seeping blood.
  • the device also incorporates a top adhesive which covers the sheath hub and side port, and ensures containment in the circular cross-sectioned pad. With the circular cross-sectioned pad with side ribs, and the adhesive bonds, any interventional sheath can be held rigidly throughout a procedure.
  • FIG. 1 is a perspective view of a sheath that is useful with the invention
  • FIG. 2 is a top plan view of the access site management device
  • FIG. 3 is a perspective view of the access site management device that is partially deployed showing engagement of the sheath side port in the device side channel;
  • FIG. 4 is a perspective view of the access site management device that is fully deployed showing the adhesive attachment to the skin;
  • FIG. 5 is the same view as FIG. 4 taken from a different direction of the access site management device showing the adhesive attachment to the sheath with exposure of the proximal end of the sheath;
  • FIG. 6 is a top plan view of an alternative embodiment of a access site management device.
  • FIG. 7 is the same view as FIG. 3 of the embodiment in FIG. 6.
  • the present invention is embodied in an access site management device and method whose goal is to securely retain the sheath throughout the procedure without being affected by movement of devices through the sheath.
  • FIG. 1 shows a typical interventional sheath 10.
  • a typical interventional sheath 10 contains a cylindrical hub 11, a proximal side 12 with an insertion hole 13.
  • the sheath 10 has a side port 14 which exits the hub 11 normal to the axis of the hub.
  • the sheath 10 has a tubular portion 15 which extends from the distal side 16 of the cylindrical hub 11.
  • FIG. 2 shows a top view of the securement device 20.
  • the securement device 20 has a circumferential adhesive pad 21 which can be directly connected with the patient by a wrap around an extremity, such as the wrist or ankle of a patient.
  • adhesive pad 21 can be indirectly connected with the patient, such as by attachment of the pad to a drape around the procedure site. Attached to the adhesive pad 21 is the partial-circular cross-sectioned retention pad 22.
  • the retention pad 22 contains a partial-circular section 23 for locating and holding the hub of the sheath.
  • the retention pad 22 also contains side ribs 24 which locate and hold the side port of the sheath.
  • the securement device 20 also contains a top retention strip 25 for containing the sheath when placed into the retention pad. Retention strip 25 may be retained by adhesive, Velcro, clips, or the like. In the illustrated embodiment, retention strip 25 is retained by adhesive.
  • FIG. 3 shows a perspective view of the securement device 20 with adhesive pad 21 retained to the patient's wrist.
  • the adhesive pad can be attached to the patient prior to deploying the access lumen 10 thereby avoiding adherence problems from trying to apply adhesive over a site that has blood or other fluids present.
  • sheath 10 is then inserted in the patient's vessel and cylindrical hub 11 is installed in the retention pad 22.
  • the figure shows the engagement of the sheath hub 11 in retention pad 22, and the engagement of the side port 14 with the side ribs 24 of the retention pad 22.
  • FIG. 4 shows the application of retention strip 25 to retain sheath 10 to retention pad 22 after circumferential adhesion of the adhesive pad 21 around the wrist of the patient and deployment of sheath 10.
  • FIG. 5 shows the securement device 20 with the sheath 10 installed in the retention pad 22.
  • the figure shows the top adhesive 25 covering and containing the sheath 10 in the retention pad 22.
  • the figure shows the open access to the insertion hole 13 in the proximal side 12 of the sheath for access to insertion hole 13 during the interventional cardiology procedure.
  • An alternative embodiment 120 of an interventional cardiology access lumen site management device has the same features as site management device 20 except that it has an adhesive pad 121 that is similar to adhesive pad 21 except that it has a through- channel 132 defined therein.
  • Site management device 120 further has a top retention strip 125 that is similar to top retention device 25 to retain a stent against a retention pad (not shown) that is similar to retention pad 22 with a partial circular surface (not shown) that is similar to section 23 formed therein.
  • top retention strip 125 has a through-channel 130 that aligns with through-channel 132. Through-channels 130, 132 accommodate a tubular extension of side port 14 of stent 10 to allow more freedom of movement of the extension of side port 14.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un procédé de gestion d'un dispositif de gestion de site d'accès et de site pour une lumière d'accès de cardiologie d'intervention ayant un embout cylindrique et une partie tubulaire s'étendant depuis l'embout cylindrique, qui comprend l'adhérence directe ou indirecte d'un tampon adhésif à un patient à un site d'accès de cardiologie d'intervention. Après l'adhérence, une lumière d'accès est déployée et une partie de la lumière d'accès est positionnée contre un tampon de retenue qui est retenu par le tampon adhésif. Le tampon de retenue a une surface configurée pour la partie de la lumière d'accès. La lumière d'accès est retenue au tampon de retenue à l'aide d'une bande de retenue supérieure.
PCT/US2013/063802 2012-10-09 2013-10-08 Procédé et dispositif de gestion de site d'intervention de gaines et de cathéters WO2014058828A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/682,347 US20150217088A1 (en) 2012-10-09 2015-04-09 Method and device for interventional site management of sheaths and catheters

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261711533P 2012-10-09 2012-10-09
US61/711,533 2012-10-09

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/682,347 Continuation-In-Part US20150217088A1 (en) 2012-10-09 2015-04-09 Method and device for interventional site management of sheaths and catheters

Publications (2)

Publication Number Publication Date
WO2014058828A2 true WO2014058828A2 (fr) 2014-04-17
WO2014058828A3 WO2014058828A3 (fr) 2015-07-16

Family

ID=50478043

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/063802 WO2014058828A2 (fr) 2012-10-09 2013-10-08 Procédé et dispositif de gestion de site d'intervention de gaines et de cathéters

Country Status (1)

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WO (1) WO2014058828A2 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4726716A (en) * 1986-07-21 1988-02-23 Mcguire Thomas V Fastener for catheter
DK193991D0 (da) * 1991-11-29 1991-11-29 Nicomed Aps A bandage for fixating a cannula of a venous catheter relative to a skin surface part of a person
US5707703A (en) * 1994-03-10 1998-01-13 Minnesota Mining And Manufacturing Company Refastenable tube and cable restraint for medical use
US7204827B2 (en) * 2004-02-26 2007-04-17 Maddoc Medical Products, Inc. Securement device for indwelling catheters or introducers
WO2007035605A2 (fr) * 2005-09-19 2007-03-29 Medical Device Group, Inc. Assemblage de fixation de tubage medical et ses methodes d'utilisation
US9138560B2 (en) * 2006-01-12 2015-09-22 Venetec International, Inc. Universal catheter securement device
WO2010016837A1 (fr) * 2008-08-06 2010-02-11 Venetec International, Inc. Système d'ancrage à taquets

Also Published As

Publication number Publication date
WO2014058828A3 (fr) 2015-07-16

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